Melynn Nuite

Background

About Melynn Nuite

PROFESSIONAL EXPERIENCE Dynamic, diverse, and very experienced RN and research professional having managed and coordinated research programs in academic, community practice, and government settings. Research work includes VA CSP, NCI, NIH (NIAMS and NHLBI), pharmaceutical, biotech sponsored, and investigator initiated protocols. AREAS OF EXPERTISE Clinical Trials Management ICH, GCP Expertise Phase II, IV Protocols Protocol development ICF development and documentation Recruitment Regulatory Expertise Protocol Training Budget Development Contract Negotiation SUMMARY OF QUALIFICATIONS Successfully managed and coordinated 59 protocols. Fostered an environment of strong staff-to-patient rapport translating to a low subject drop out rate of < 10 %. Conscientious and detail oriented, while making participant safety a constant priority. Collaborate with PIs and physicians regarding protocol selection that is most appropriate and feasible to practice. Ensure compliance with required training e.g, human subjects, protocol, and eCRF for research staff, PI, and ancillary research team members. Complete internal monitoring and used findings to improve and strengthen research program. Liaise with human subjects research committee members, core laboratories, PIs, and Sub-Is to ensure protocol compliance and quality data collection. Timely completion and submission of study required reports e.g, SAE and IRB.